Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT04406740

Collaborator

(none)

Enrollment

Location

65.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: TwitchView EMG Unit Device: Novel QTOF Device

Detailed Description

The disposable stimulus/recording electrode array for the TwitchView will be placed on one of the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and thenar eminence. The devices will be placed prior to the induction of anesthesia - but no electrical stimuli will be delivered until AFTER the patient is asleep (as per routine). After induction, both devices will be started. The TwitchView automatically selects the appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF stimulus current will be set to the same value. The stimulus interval for both devices will be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the entirety of the surgical procedure, and cross checked with Epic regarding the administration of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be present to verify the correct function of both devices. Note that information from the TwitchView monitor will be continuous available to the providers (it is a standard device available for use in our ORs). Information from the QTOF will NOT be made available to providers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Actual Study Start Date :

Jun 18, 2018

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
All Participants Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.	Device: TwitchView EMG Unit The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes. Device: Novel QTOF Device The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).

Arm

Intervention/Treatment

All Participants

Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.

Device: TwitchView EMG Unit

The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.

Device: Novel QTOF Device

The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).

Outcome Measures

Primary Outcome Measures

Train-of-Four (TOF) Ratio [420 minutes]
The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated

Exclusion Criteria:

Emergent procedures will be excluded
Procedures performed outside of regular Monday to Friday working hours will be excluded
Inability to provide their own consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MHealth Farview University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Michael Todd, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT04406740

Other Study ID Numbers:

ANES-2020-28905

First Posted:

May 28, 2020

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 29, 2022